A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY OF NIVOLUMAB COMBINED WITH IPILIMUMAB VERSUS STANDARD OF CARE CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED UNRESECTABLE OR METASTATIC UROTHELIAL CANCER

Not Applicable

Recruiting

• Conditions: -C791 Secondary malignant neoplasm of bladder and other and unspecified urinary organs; Secondary malignant neoplasm of bladder and other and unspecified urinary organs; C791

• Registration Number: PER-008-17
• Lead Sponsor: A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-05
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

This will be a randomized, open-label, Phase 3 study comparing combination therapy of
nivolumab (1 mg/kg 30 minute IV infusion) plus ipilimumab (3 mg/kg 30 minute IV infusion)
administered every 3 weeks for up to four doses, followed by nivolumab monotherapy (480 mg
30 minute IV infusion) administered every 4 weeks, versus the standard of care (SOC;
gemcitabine-cisplatin or gemcitabine-carboplatin) in participants with previously untreated unresectable or metastatic UC. Participants will be randomized 1:1 to treatment Arm A or B then stratified by PD-L1 status < 1%, cisplatin-eligibility, and liver metastasis.
a) Arm A (nivolumab 1 mg/kg plus ipilimumab 3 mg/kg [N1 + I3], followed by nivolumab
monotherapy)
b) Arm B (standard of care [SOC] platinum chemotherapy doublet, 3 week cycles, up to 6
cycles).

Exclusion Criteria

•Histological or cytological evidence of metastatic or surgically unresectable transitional cell carcinoma (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra. Measurable disease by CT or MRI per RECIST 1.1 criteria.
•No prior systemic chemotherapy for metastatic or surgically unresectable UC with some exceptions detailed in protocol.
•Cisplatin-ineligible participants will be defined by any one of the following criteria: i. Impaired renal function, ii. Common Terminology Criteria for Adverse Events (CTCAE) version 4, ≥ Grade 2 audiometric hearing loss, iii. CTCAE version 4, ≥ Grade 2 peripheral neuropathy
•Participants eligible for Cisplatin-based chemotherapy must exhibit adequate renal function
•Participants must have an evaluable tumor tissue (fresh biopsy [within 3 months]) prior to randomization. In order to be treated, a participants must be classified as PD-L1
•1% or PDL1 < 1% as determined by a central laboratory during the screening period.
•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 for ECOG Performance Status scale
•Adequate hematologic and liver function

Study & Design

• Study Type: Interventional
• Study Design: Not specified